Study Evaluation the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction for 10 Weeks

This study has been completed.
Information provided by (Responsible Party):
Bayer Identifier:
First received: April 18, 2008
Last updated: October 10, 2013
Last verified: October 2013
The aim of this international study was to determine if 10 weeks of flexible-dose vardenafil therapy demonstrates superior efficacy compared to the dummy drug (placebo) in Erectile dysfunction subjects of a broad etiology when dosed 8 (+/-2) hours prior to sexual intercourse. In addition it should have been determined, if subjects with ED from a broad etiology can tolerate 10 weeks of flexible-dose vardenafil therapy when dosed 8(+/-2) hours prior to sexual intercourse.

Condition Intervention Phase
Erectile Dysfunction
Drug: Levitra (Vardenafil, BAY38-9456)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Duration of Efficacy and Safety of Vardenafil Administered for 10 Weeks in a Flexible-Dose Regimen Compared to Placebo in Subjects With Erectile Dysfunction

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Per-patient success rates based on Sexual Encounter Profile, Question 3 [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Per-subject success rates based on Sexual Encounter Profile, Question 2 [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • International Index of Erectile Function- Erectile Function domain score [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Global Assessment Question (GAQ) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • Safety and tolerability [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 383
Study Start Date: December 2003
Study Completion Date: August 2004
Arms Assigned Interventions
Experimental: Arm 1 Drug: Levitra (Vardenafil, BAY38-9456)
5mg, 10mg or 20mg taken 8 hours before sexual intercourse
Placebo Comparator: Arm 2 Drug: Placebo
matching placebo


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Men >/= 18 years of age, with 6 months or longer diagnosis of ED as defined by NIH Consensus statement,
  • History of unresponsiveness to sildenafil
  • Stable sexual relationship for > 6 month.

Exclusion Criteria:

  • Primary hypoactive sexual desire
  • History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month
  • Nitrate therapy.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00682019

Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer Identifier: NCT00682019     History of Changes
Other Study ID Numbers: 100493 
Study First Received: April 18, 2008
Last Updated: October 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Erectile Dysfunction

Additional relevant MeSH terms:
Erectile Dysfunction
Genital Diseases, Male
Mental Disorders
Sexual Dysfunction, Physiological
Sexual Dysfunctions, Psychological
Vardenafil Dihydrochloride
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Urological Agents
Vasodilator Agents processed this record on May 24, 2016